{"id":492291,"date":"2021-05-12T09:20:09","date_gmt":"2021-05-12T13:20:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/"},"modified":"2021-05-12T09:20:09","modified_gmt":"2021-05-12T13:20:09","slug":"uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/","title":{"rendered":"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)"},"content":{"rendered":"
\n

Application Submitted to MHRA for Certification of Sawston Facility<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n BETHESDA, Md.<\/span>, May 12, 2021<\/span> \/PRNewswire\/ —\u00a0Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax\u00ae<\/sup> personalized immune therapies for solid tumor cancers, today announced that an application for certification of the manufacturing facility in Sawston, UK has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).\u00a0 The Company also provided a process update on the DCVax\u00ae<\/sup>-L Phase III Trial.<\/p>\n

\n

\n
\n \"Northwest
\n <\/a>\n <\/p>\n<\/p><\/div>\n

On May 7<\/span>, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients. \u00a0This application represents the culmination of more than 2 years of preparations, including more than a year conducting these efforts under challenging COVID-19 restrictions and conditions. <\/p>\n

As previously reported on March 16, 2021<\/span>, the preparations have included the physical buildout of Phase I of the facility, development of over 500 regulatory documents (including Standard Operating Procedures (SOPs) for all aspects of operations, batch manufacturing records, and other formal documents), development of a Sawston team of nearly 40 persons with all of the required types of expertise for production of Advanced Therapy Medicinal Products (ATMPs) and training in regard to the DCVax\u00ae technology and processes.\u00a0\u00a0<\/p>\n

The next step will be an on-site inspection of the facility by MHRA. \u00a0Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA.\u00a0 Following completion of any actions, the Company is hopeful that an initial license will be issued and production of GMP DCVax-L products in the Sawston facility may begin by around the end of Q3. <\/p>\n

In addition to the MHRA submission activities, a prototype of the Flaskworks system has been delivered to the Sawston facility, and the Company currently anticipates that initial practice runs with the system may begin at the Sawston facility during the summer. <\/p>\n

Meanwhile, manufacturing of vaccine products for compassionate use patients (“Specials”) has been and is continuing at the GMP facility in London<\/span>.<\/p>\n

The process outlined in the Company’s October 5, 2020<\/span> announcement relating to the Phase III trial of DCVax-L is continuing to move forward. \u00a0The process includes review and analysis of the raw data by independent statisticians and experts, and preparation of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts in preparation for public announcement and scientific publication.\u00a0 <\/p>\n

The Company continues to be in a quiet period while this process is under way. \u00a0The Company appreciates shareholders’ patience, and their understanding that the Company cannot make partial disclosures during this process and cannot comment on the Phase III trial schedule or its data until the announcement of the results. \u00a0We remain committed to completing the full plan outlined on October 5, 2020<\/span>.<\/p>\n

\n About Northwest Biotherapeutics <\/b>\n <\/p>\n

Northwest Biotherapeutics is a biotechnology company focused on developing personalized<\/p>\n

immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America<\/span> and Europe.\u00a0 The Company has a broad platform technology for DCVax\u00ae<\/sup> dendritic cell-based vaccines.\u00a0 The Company’s lead program is a 331-patient Phase III trial of DCVax\u00ae<\/sup>-L for newly diagnosed Glioblastoma multiforme (GBM).\u00a0 GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.”\u00a0 This Phase III trial is now completed, with the trial data now being analyzed.\u00a0 The Company is also pursuing development of DCVax\u00ae<\/sup>-Direct for inoperable solid tumor cancers.\u00a0 It has completed a 40-patient Phase I trial and, as resources permit, is preparing for Phase II trials.\u00a0 The Company previously conducted a Phase I\/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania<\/span>.\u00a0<\/i><\/b><\/p>\n

\n
\n Disclaimer<\/i>
\n <\/b>
\n \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/i>\n <\/p>\n

\n Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.\u00a0 Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.\u00a0 We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements.\u00a0 Actual results may differ materially from those projected in any forward-looking statement.\u00a0 Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings.\u00a0 Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings.\u00a0 Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement.\u00a0 The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.<\/i>\n <\/p>\n

\n\n\n\n\n\n
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\n CONTACTS\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/b>
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\n \n <\/td>\n<\/tr>\n
\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
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\n Dave Innes\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>\n <\/p>\n<\/td>\n

\n

\n Les Goldman<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

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\n 804-513-4758\u00a0\u00a0 dinnes@nwbio.com<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span>\n <\/p>\n<\/td>\n

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\n 240-234-0059\u00a0\u00a0 lgoldman@nwbio.com<\/a><\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

\u00a0<\/p>\n

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\n \"Cision\" View original content to download multimedia:http:\/\/www.prnewswire.com\/news-releases\/uk-manufacturing-facility–phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo-301289852.html<\/a><\/p>\n

SOURCE Northwest Biotherapeutics<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

Application Submitted to MHRA for Certification of Sawston Facility PR Newswire BETHESDA, Md., May 12, 2021 \/PRNewswire\/ —\u00a0Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax\u00ae personalized immune therapies for solid tumor cancers, today announced that an application for certification of the manufacturing facility in Sawston, UK has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).\u00a0 The Company also provided a process update on the DCVax\u00ae-L Phase III Trial. On May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients. \u00a0This application represents the culmination of more than 2 years of preparations, including more than a … <\/p>\n

Continue reading “UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-492291","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nUK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO) - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Application Submitted to MHRA for Certification of Sawston Facility PR Newswire BETHESDA, Md., May 12, 2021 \/PRNewswire\/ —\u00a0Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax\u00ae personalized immune therapies for solid tumor cancers, today announced that an application for certification of the manufacturing facility in Sawston, UK has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).\u00a0 The Company also provided a process update on the DCVax\u00ae-L Phase III Trial. On May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients. \u00a0This application represents the culmination of more than 2 years of preparations, including more than a … Continue reading "UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-05-12T13:20:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/325355\/northwest_biotherapeutics__inc__logo.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)\",\"datePublished\":\"2021-05-12T13:20:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\\\/\"},\"wordCount\":957,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/325355\\\/northwest_biotherapeutics__inc__logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\\\/\",\"name\":\"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO) - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/","og_locale":"en_US","og_type":"article","og_title":"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO) - Market Newsdesk","og_description":"Application Submitted to MHRA for Certification of Sawston Facility PR Newswire BETHESDA, Md., May 12, 2021 \/PRNewswire\/ —\u00a0Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax\u00ae personalized immune therapies for solid tumor cancers, today announced that an application for certification of the manufacturing facility in Sawston, UK has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).\u00a0 The Company also provided a process update on the DCVax\u00ae-L Phase III Trial. On May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients. \u00a0This application represents the culmination of more than 2 years of preparations, including more than a … Continue reading \"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/","og_site_name":"Market Newsdesk","article_published_time":"2021-05-12T13:20:09+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/325355\/northwest_biotherapeutics__inc__logo.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)","datePublished":"2021-05-12T13:20:09+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/"},"wordCount":957,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/325355\/northwest_biotherapeutics__inc__logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/uk-manufacturing-facility-phase-iii-trial-updates-from-northwest-biotherapeutics-otcqb-nwbo\/","name":"UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO) - 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